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Randomized Controlled Trial
. 2023 Oct;8(5):399-404.
doi: 10.1136/svn-2022-002075. Epub 2023 Mar 27.

Comparison of carotid endarterectomy and repeated carotid angioplasty and stenting for in-stent restenosis (CERCAS trial): a randomised study

Tomáš Hrbáč  1   2 , Jiří Fiedler  3 , Václav Procházka  4 , Tomáš Jonszta  4 , Martin Roubec  5 , David Pakizer  6 , Daniel Václavík  7 , David Netuka  8 , Tomáš Heryán  6 , David Školoudík  9   6
Affiliations
Randomized Controlled Trial

Comparison of carotid endarterectomy and repeated carotid angioplasty and stenting for in-stent restenosis (CERCAS trial): a randomised study

Tomáš Hrbáč et al. Stroke Vasc Neurol. 2023 Oct.

Abstract

Background and aim: In-stent restenosis (ISR) belongs to an infrequent but potentially serious complication after carotid angioplasty and stenting in patients with severe carotid stenosis. Some of these patients might be contraindicated to repeat percutaneous transluminal angioplasty with or without stenting (rePTA/S). The purpose of the study is to compare the safety and effectiveness of carotid endarterectomy with stent removal (CEASR) and rePTA/S in patients with carotid ISR.

Methods: Consecutive patients with carotid ISR (≥80%) were randomly allocated to the CEASR or rePTA/S group. The incidence of restenosis after intervention, stroke, transient ischaemic attack myocardial infarction and death 30 days and 1 year after intervention and restenosis 1 year after intervention between patients in CEASR and rePTA/S groups were statistically evaluated.

Results: A total of 31 patients were included in the study; 14 patients (9 males; mean age 66.3±6.6 years) were allocated to CEASR and 17 patients (10 males; mean age 68.8±5.6 years) to the rePTA/S group. The implanted stent in carotid restenosis was successfully removed in all patients in the CEASR group. No clinical vascular event was recorded periproceduraly, 30 days and 1 year after intervention in both groups. Only one patient in the CEASR group had asymptomatic occlusion of the intervened carotid artery within 30 days and one patient died in the rePTA/S group within 1 year after intervention. Restenosis after intervention was significantly greater in the rePTA/S group (mean 20.9%) than in the CEASR group (mean 0%, p=0.04), but all stenoses were <50%. Incidence of 1-year restenosis that was ≥70% did not differ between the rePTA/S and CEASR groups (4 vs 1 patient; p=0.233).

Conclusion: CEASR seems to be effective and save procedures for patients with carotid ISR and might be considered as a treatment option.

Trial registration number: NCT05390983.

Keywords: angioplasty; carotid stenosis; intervention; stents; stroke.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Carotid endarterectomy with stent removal in patients with carotid in-stent restenosis. Carotid in-stent restenosis on digital subtraction angiography before surgery (A), stent removal during carotid endarterectomy (B), removed stent with atherosclerotic plaque after carotid endarterectomy (B) and histology of atherosclerotic plaque with a stent (B).
Figure 2
Figure 2
Repeat percutaneous transluminal angioplasty in patient with carotid in-stent restenosis. Carotid in-stent restenosis on digital subtraction angiography before angioplasty (A) and residual in-stent stenosis after angioplasty (B).
See this image and copyright information in PMC

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